Last Updated on December 31, 2023 by The Health Master
The US Food and Drug Administration (USFDA) has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) single-dose vials, a statement from Alembic Pharma notified.
This is the second injectable product approval by the company’s General Sterile Facility (F-3), which was inspected in August 2022, according to the statement.
It also said that the approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Toradol injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, of Roche Palo Alto.
Further, as per the statement, ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.
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